[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR160.120]



[Page 151-152]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

              Subpart G_Protocol for and Conduct of a Study

 

Sec. 160.120  Protocol.





    (a) Each study shall have an approved written protocol that clearly 

indicates the objectives and all methods for the conduct of the study. 

The protocol shall contain but shall not necessarily be limited to the 

following information:

    (1) A descriptive title and statement of the purpose of the study.

    (2) Identification of the test, control, and reference substance by 

name, chemical abstracts service (CAS) number or code number.

    (3) The name and address of the sponsor and the name and address of 

the testing facility at which the study is being conducted.

    (4) The proposed experimental start and termination dates.

    (5) Justification for selection of the test system.

    (6) Where applicable, the number, body weight range, sex, source of 

supply, species, strain, substrain, and age of the test system.

    (7) The procedure for identification of the test system.

    (8) A description of the experimental design, including methods for 

the control of bias.

    (9) Where applicable, a description and/or identification of the 

diet used in the study as well as solvents, emulsifiers and/or other 

materials used to solubilize or suspend the test, control, or reference 

substances before mixing with the carrier. The description shall include 

specifications for acceptable levels of contaminants that are reasonably 

expected to be present in the dietary materials and are known to be 

capable of interfering with the purpose or



[[Page 152]]



conduct of the study if present at levels greater than established by 

the specifications.

    (10) The route of administration and the reason for its choice.

    (11) Each dosage level, expressed in milligrams per kilogram of body 

or test system weight or other appropriate units, of the test, control, 

or reference substance to be administered and the method and frequency 

of administration.

    (12) The type and frequency of tests, analyses, and measurements to 

be made.

    (13) The records to be maintained.

    (14) The date of approval of the protocol by the sponsor and the 

dated signature of the study director.

    (15) A statement of the proposed statistical method to be used.

    (b) All changes in or revisions of an approved protocol and the 

reasons therefore shall be documented, signed by the study director, 

dated, and maintained with the protocol.